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Histology & Cytology Market Forecasts to 2028 – Global Analysis By Technique (Molecular Pathology, Cryostat & Microtomy), Type of Examination, Product, Test Type, Application, End User, and By Geography
Estimated Year Value (2021)
US $16.29 BN
Projected Year Value (2028)
US $44.66 BN
CAGR (2021 - 2028)
North America, Europe, Asia Pacific, South America, and Middle East & Africa
US, Canada, Mexico, Germany, UK, Italy, France, Spain, Japan, China, India, Australia, New Zealand, South Korea, Rest of Asia Pacific, South America, Argentina, Brazil, Chile, Middle East & Africa, Saudi Arabia, UAE, Qatar, and South Africa
Highest Growing Market
According to Stratistics MRC, the Global Histology & Cytology Market is accounted for $16.29 billion in 2021 and is expected to reach $44.66 billion by 2028 growing at a CAGR of 15.5% during the forecast period. Cytology can be defined as the microscopic study of cell sample, which can be collected from any part of the body such as lungs, vagina, kidney, and others to assess the presence of irregular growth or lumps on the body surface. Cytology can also be used to assess abnormal body fluids that may accumulate in areas such as chest and abdomen region. Histology can be defined as the microscopic study of structural and chemical properties of body tissues. Histology is used extensively in the field of biomedical research and clinical diagnostics to diagnose diseases such as cancer, infectious diseases, and inflammatory diseases and to develop novel therapeutics for these diseases. The most common technique used to collect cytology cell sample is fine needle biopsy, which is also called fine needle aspiration wherein, a sterile needle attached to an empty syringe is inserted into the target tissue such as skin lump, joint, and others to aspirate either cells or body fluid. Other sample collection techniques such as skin scrapping, cotton tipped swab, smear, and others may also be used for cytological studies. Cytology can be used as a preliminary diagnostic tool for detection of cancer.
Cytopathology practices continue to struggle with the performance of cytologic-histologic correlation (CHC) and what to do with the results. For practices in the United States, the Clinical Laboratory Improvement Amendments (CLIA) require “laboratory comparison of clinical information, when available, with cytology reports and comparison of all gynecologic cytology reports with a diagnosis of high-grade squamous intraepithelial lesion (HSIL), adenocarcinoma, or other malignant neoplasms with the histopathology report, if available in the laboratory (either on-site or in storage), and determination of the causes of any discrepancies.
Increasing prevalence of cancer globally
The increasing burden of cancer on society is found to be a major threat to the developing countries, owing to lower disposable income and dynamic demographics. Cancer has been the leading cause for mortality, globally and has resulted in deaths that have accounted for the largest share of mortality. Thus, the growing prevalence of cancer patients has a direct impact on the increased demand for the histology and cytology market. Globally, about 1 in 6 deaths is due to cancer. About 70% of deaths from cancer occur in low- and middle-income countries. These histological methods thus help in increasing the sensitivity, specificity, and accuracy of diagnostic methods. Similarly, the combined methods help in the better diagnosis of diseases, such as breast and lung cancer. Thus, the prevalence of cancer plays a vital role in increasing the demand of the histology and cytology market. Hence globally, there has been a growing adoption of cytological tests due to its less invasive nature as compared to biopsy and higher reliability.
Lack of awareness among the public for diagnostic tests
The major obstacles to its widespread establishment are lack of awareness and inadequate numbers of trained personnel compounded by sociopolitical factors, poor national planning and implementation. Rather than investing in new technology or alternative screening methods, efforts should focus on the education and training of local personnel, as feasible options, to improve the chances of implementing meaningful cancer control programs. There is a large untapped pool of trainable manpower in most of these countries. With available trained personnel in the field to handle the services and advocate for change, the chances of making screening programs feasible would be improved.
Integration of digital technologies
The onset of digital technologies is likely to shape the future of the global histology & cytology market in terms of boosting efficiency and scalability. The growing adoption of digital technologies is expected to accelerate the speed and accuracy of diagnosis due to which, the concept of digital pathology is gaining considerable traction worldwide. The increasing adoption of digital whole-slide-imaging (WSI) enables pathologists to visualize and capture the complete tissue on the slide in comparison with the view provided by the microscope– a factor that is expected to improve the accuracy of pathological processes and minimize its subjectivity. Digital slides pave the way for computer-assisted quantitative analytics, speedier image search, and efficient retrieval of slides. Advancements in precision medicine and AI are anticipated to improve care delivery due to which, more number of pathologists around the world are increasing embracing digital technologies. This factor is likely to provide a boost to the global histology & cytology market during the assessment period.
Stringent regulations from government
The stringent regulations policies from the government are anticipated to curtail growth in the histology and cytology market. This is due to the complicated procedures that are closely linked to histology and cytology. For instance, according to an article published by the National center for Biotechnology Information (NCBI) in May 2021, histological specimen slide preparation involves a number of steps such as fixation, dehydration, embedding, sectioning, and others which can prove to be a complicated and time consuming task. These may also hamper growth opportunities in the histology and cytology industry.
The drug discovery & designing segment is expected to be the largest during the forecast period
The drug discovery & designing segment is estimated to have a lucrative growth. The growth of the segment can be attributed to the wide use of histomorphometry and IHC staining in pharmaceutical and biotechnology companies for drug development. The image analysis is applied across several steps of drug discovery and development such as drug efficacy and safety studies, target validation, drug repositioning, patient stratification, and biomarker expression studies.
The cytology segment is expected to have the highest CAGR during the forecast period
The cytology segment is anticipated to witness the fastest CAGR growth during the forecast period. The cytology segment has a wide range of applications in multiple cancer types. Cytology tests are useful for both the diagnosis and screening of various cancer types. Due to the observations at the cellular levels, the companies primarily prefer cytology-based diagnostic methods. Since in the coming decade, companies are focusing on diagnosis at the molecular level, cytology is expected to play a vital role. The cost of histological tests is higher than cytology studies, mainly due to the multiple phases involved in its preparation, whereas no such stages are classified for cytology slides. According to the World Health Organization (WHO), estimates that breast cancer is the most frequent cancer among women, impacting 2.1 million women every year globally, and responsible for a higher number of cancer-related deaths among women. Hence, due to the aforementioned factors, the demand for cytological methods is expected to boost the market growth.
Region with highest share:
North America is projected to hold the largest market share during the forecast period due to the increasing geriatric population, growing cancer incidence and raising awareness about cancer screening in the region. According to the American Cancer Society, cancer is the second most common cause of death in the United States, exceeded only by heart disease. Furthermore, awareness pertaining to advance therapeutics and presence of well-established healthcare infrastructure is also fuelling the growth of the overall regional market to a large extent. Hence, all these factors are expected to help propel the histology and cytology market in the North America region.
Region with highest CAGR:
Asia Pacific is projected to have the highest CAGR over the forecast period owing to the several factors such as the rising cancer awareness, a large target population, and improving healthcare infrastructure. In addition, researchers are increasingly evaluating new cytology, which is further fueling the growth of the market in the region. For instance, in February 2020, researchers in Japan evaluated the efficacy of liquid-based cytology over conventional cytology in cervical cancer screening. The results of the study indicated that liquid-based cytology was comparatively more useful than conventional cytology from practical standpoints.
Key players in the market
Some of the key players profiled in the Histology & Cytology Market include Autoliv Inc, BMW, Continental AG, DCS Systems Ltd, Delphi Automotive LLP, Falcon Electronics LLC, Ficosa International S.A, GoPro Inc, KYOCERA Corporation, Media Data Systems Pte Ltd, Qrontech Co. Ltd, Robert Bosch GmbH, Transcend Information Inc, Valeo Inc, and S.Will Industrial Ltd.
In May 2021, Hologic, Inc., received premarket approval from the U.S. FDA for its ThinPrep Genesis Processor. This instrument combines sample aliquoting and cytology processing with improved workflow.
In June 2021, Antech Diagnostics introduced a Digital Cytology Scanner in North America. This scanner allows the delivery of whole-slide interpretations within 2 hours, which facilitates in reducing the examination time and assessing a large number of samples at POC settings.
In January 2021, F. Hoffmann-La Roche Ltd. launched uPath HER2 Dual ISH image analysis and uPath HER2 (4B5) image analysis—two automated digital pathology algorithms for breast cancer. These two solutions offer rapid and accurate patient diagnoses in breast cancer.
• Molecular Pathology
• Cryostat & Microtomy
Type of examinations Covered:
• Instruments and Analysis Software System
• Consumable and Reagents
Test Types Covered:
• Molecular Genetics Tests (Cytogenic Tests)
• Microscopy Tests
• Flow Cytometry
• Polymerase Chain Reaction
• Clinical Diagnostics
• Cell Signaling
• Epigenetics and Sequencing Studies
• Molecular Diagnostics
• Drug Discovery & Designing
End Users Covered:
• Diagnostic Laboratories/Centers
• Academic & Research Institutes
• Biopharmaceutical Companies
• Life Sciences
• North America
o Rest of Europe
• Asia Pacific
o New Zealand
o South Korea
o Rest of Asia Pacific
• South America
o Rest of South America
• Middle East & Africa
o Saudi Arabia
o South Africa
o Rest of Middle East & Africa
What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2020, 2021, 2022, 2025, and 2028
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements
Free Customization Offerings:
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
o Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances
Table of Contents
1 Executive Summary
2.2 Stake Holders
2.3 Research Scope
2.4 Research Methodology
2.4.1 Data Mining
2.4.2 Data Analysis
2.4.3 Data Validation
2.4.4 Research Approach
2.5 Research Sources
2.5.1 Primary Research Sources
2.5.2 Secondary Research Sources
3 Market Trend Analysis
3.6 Product Analysis
3.7 Application Analysis
3.8 End User Analysis
3.9 Emerging Markets
3.10 Impact of Covid-19
4 Porters Five Force Analysis
4.1 Bargaining power of suppliers
4.2 Bargaining power of buyers
4.3 Threat of substitutes
4.4 Threat of new entrants
4.5 Competitive rivalry
5 Global Histology & Cytology Market, By Technique
5.2 Molecular Pathology
5.3 Cryostat & Microtomy
6 Global Histology & Cytology Market, By Type of Examination
6.3.1 Oral Cancer
6.3.2 Breast Cancer
6.3.3 Lung Cancer
6.3.4 Cervical Cancer
6.3.5 Other Cancers
220.127.116.11 Bladder Cancer
18.104.22.168 Bile Duct
22.214.171.124 Pancreatic Cancer
126.96.36.199 Infectious Diseases
188.8.131.52 Inflammatory Diseases
7 Global Histology & Cytology Market, By Product
7.2 Instruments and Analysis Software System
7.3 Consumable and Reagents
8 Global Histology & Cytology Market, By Test Type
8.2 Molecular Genetics Tests (Cytogenic Tests)
8.2.1 Fluorescent In-Situ Hybridization (FISH)
8.3 Microscopy Tests
8.3.1 Immunohistochemistry and Immunofluorescence
8.3.2 Cytochemistry and Histochemistry
8.4 Flow Cytometry
8.5 Polymerase Chain Reaction
9 Global Histology & Cytology Market, By Application
9.2 Clinical Diagnostics
9.2.1 Point-of-Care (PoC)
9.3 Cell Signaling
9.4 Epigenetics and Sequencing Studies
9.5 Molecular Diagnostics
9.6 Drug Discovery & Designing
10 Global Histology & Cytology Market, By End User
10.2 Diagnostic Laboratories/Centers
10.3 Academic & Research Institutes
10.4 Biopharmaceutical Companies
10.5 Life Sciences
11 Global Histology & Cytology Market, By Geography
11.2 North America
11.3.6 Rest of Europe
11.4 Asia Pacific
11.4.5 New Zealand
11.4.6 South Korea
11.4.7 Rest of Asia Pacific
11.5 South America
11.5.4 Rest of South America
11.6 Middle East & Africa
11.6.1 Saudi Arabia
11.6.4 South Africa
11.6.5 Rest of Middle East & Africa
12 Key Developments
12.1 Agreements, Partnerships, Collaborations and Joint Ventures
12.2 Acquisitions & Mergers
12.3 New Product Launch
12.5 Other Key Strategies
13 Company Profiling
13.2 AirClean Systems, Inc
13.3 Antech Diagnostics
13.4 Becton, Dickinson and Company
13.6 F. Hoffmann-La Roche Ltd.
13.7 Hologic, Inc.
13.8 Kinetic River Corp.
13.9 Koninklijke Philips N.V.
13.11 Merck KGaA
13.12 PerkinElmer, Inc.
13.13 Sysmex Corporation
13.14 Thermo Fisher Scientific, Inc.
13.15 Trivitron Healthcare
List of Tables
1 Global Histology & Cytology Market Outlook, By Region (2020-2028) ($MN)
2 Global Histology & Cytology Market Outlook, By Technique (2020-2028) ($MN)
3 Global Histology & Cytology Market Outlook, By Molecular Pathology (2020-2028) ($MN)
4 Global Histology & Cytology Market Outlook, By Cryostat & Microtomy (2020-2028) ($MN)
5 Global Histology & Cytology Market Outlook, By Type of Examination (2020-2028) ($MN)
6 Global Histology & Cytology Market Outlook, By Histology (2020-2028) ($MN)
7 Global Histology & Cytology Market Outlook, By Cytology (2020-2028) ($MN)
8 Global Histology & Cytology Market Outlook, By Oral Cancer (2020-2028) ($MN)
9 Global Histology & Cytology Market Outlook, By Breast Cancer (2020-2028) ($MN)
10 Global Histology & Cytology Market Outlook, By Lung Cancer (2020-2028) ($MN)
11 Global Histology & Cytology Market Outlook, By Cervical Cancer (2020-2028) ($MN)
12 Global Histology & Cytology Market Outlook, By Other Cancers (2020-2028) ($MN)
13 Global Histology & Cytology Market Outlook, By Product (2020-2028) ($MN)
14 Global Histology & Cytology Market Outlook, By Instruments and Analysis Software System (2020-2028) ($MN)
15 Global Histology & Cytology Market Outlook, By Consumable and Reagents (2020-2028) ($MN)
16 Global Histology & Cytology Market Outlook, By Test Type (2020-2028) ($MN)
17 Global Histology & Cytology Market Outlook, By Molecular Genetics Tests (Cytogenic Tests) (2020-2028) ($MN)
18 Global Histology & Cytology Market Outlook, By Fluorescent In-Situ Hybridization (FISH) (2020-2028) ($MN)
19 Global Histology & Cytology Market Outlook, By Karyotyping (2020-2028) ($MN)
20 Global Histology & Cytology Market Outlook, By Microscopy Tests (2020-2028) ($MN)
21 Global Histology & Cytology Market Outlook, By Immunohistochemistry and Immunofluorescence (2020-2028) ($MN)
22 Global Histology & Cytology Market Outlook, By Cytochemistry and Histochemistry (2020-2028) ($MN)
23 Global Histology & Cytology Market Outlook, By Flow Cytometry (2020-2028) ($MN)
24 Global Histology & Cytology Market Outlook, By Polymerase Chain Reaction (2020-2028) ($MN)
25 Global Histology & Cytology Market Outlook, By Application (2020-2028) ($MN)
26 Global Histology & Cytology Market Outlook, By Clinical Diagnostics (2020-2028) ($MN)
27 Global Histology & Cytology Market Outlook, By Point-of-Care (PoC) (2020-2028) ($MN)
28 Global Histology & Cytology Market Outlook, By Non-Point-of-Care (2020-2028) ($MN)
29 Global Histology & Cytology Market Outlook, By Cell Signaling (2020-2028) ($MN)
30 Global Histology & Cytology Market Outlook, By Epigenetics and Sequencing Studies (2020-2028) ($MN)
31 Global Histology & Cytology Market Outlook, By Molecular Diagnostics (2020-2028) ($MN)
32 Global Histology & Cytology Market Outlook, By Drug Discovery & Designing (2020-2028) ($MN)
33 Global Histology & Cytology Market Outlook, By Research (2020-2028) ($MN)
34 Global Histology & Cytology Market Outlook, By End User (2020-2028) ($MN)
35 Global Histology & Cytology Market Outlook, By Diagnostic Laboratories/Centers (2020-2028) ($MN)
36 Global Histology & Cytology Market Outlook, By Academic & Research Institutes (2020-2028) ($MN)
37 Global Histology & Cytology Market Outlook, By Biopharmaceutical Companies (2020-2028) ($MN)
38 Global Histology & Cytology Market Outlook, By Life Sciences (2020-2028) ($MN)
39 Global Histology & Cytology Market Outlook, By Hospitals/Clinic (2020-2028) ($MN)
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.
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